OBA

Not yet recruitingPhase 2

Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of 20-hydroxyecdysone (20E) in Reducing the Muscle Strength Loss From the GLP1 Agonist Semaglutide in Combination With Dieting in Obese and Overweight Adult Patients (OBA).

Lead sponsor

Biophytis

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

164

Study population

Obesity / overweight, Sarcopenia / muscle

Eligibility highlights

•BMI ≥30

Primary endpoint

•The knee extension strength

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07411378

Org study IDBIO101-CL10

Timeline

Milestones

Study first posted2026-02-13actual

Last update posted2026-02-13actual

Study start2026-07estimated (month precision)

Primary completion2027-06estimated (month precision)

Study completion2027-08estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightSarcopenia / muscle

Who can enroll

Minimum age18 Years

Maximum age84 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Willing to participate and able to sign an ICF

•BMI ≥30 or BMI ≥27 with one or more weight-associated co-morbidities (e.g. hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease)

•Start of treatment with semaglutide for weight loss at Day 3 after the start of the study treatment

•Willing to maintain a diet with an average intake of at least 1 gr/kg body weight protein daily

•Willing to maintain sufficient exercise, i.e. at least 150 minutes per week moderate-vigorous exercise

•Body weight stable (within a 5 kg range) in the 3 months prior to enrolment

•Female participants should be at least 12 months post-menopausal) or surgically sterile OR have a negative urine pregnancy test at screening and be willing to use a contraceptive method from screening to 90 days after last dose.

•Based on Semaglutide long half-life, participants should consent to use a contraception method 3 months after administration of the last dose intake of semaglutide.

Exclusion criteria

•Participant not able to take medications by mouth (as capsules)

•Use of disallowed concomitant medications or herbal products: Any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga, or Cyanotis arachnoidea are not allowed and any other anabolic products, GH/IGF-1 products, spironolactone, metformin, chemotherapeutic agents, antidepressants, and systemic glucocorticoids within three months prior to study enrollment or strong inhibitors of the Organic Anion Transporting Polypeptide (OATP1B3) e.g. rifampicin and cyclosporine. Use of muscle strength-supporting food supplements

•Any known hypersensitivity to any of the active substances (20E), and its excipients (the study medication) and the active substance and the excipients of semaglutide.

•History or present cholelithiasis or cholecystectomy from medical history or sludge or stones observed on gallbladder ultrasound or any other method.

•Presence of contra-indications to semaglutide per current semaglutide Prescribing Information / Summary of Product Characteristics

•Current diabetes (both insulin dependent and T2DM)

•A history of chronic pancreatitis or acute pancreatitis

•Previous surgical obesity treatment or planned obesity surgery during the study period

•Use of anti-obesity (weight-loss) medication or use of any GLP-1 RA for diabetes within 90 days before enrollment

•BMI >40

•Uncontrolled hypertension (RR above 150/100 mmHg)

•NYHA Class III or IV CHF

•History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening

•Clinically significant liver disease, ALT/AST >5x ULN, or total bilirubin > 2x ULN, unless the patient has known Gilbert's syndrome

•Neuromuscular disorder or CK >5x ULN

•Autoimmune/inflammatory disorders that may cause muscle wasting

•Use of antipsychotics, amphetamines, or any other treatments that can affect weight

•Clinically significant ECG abnormalities

•History of major depressive disorder within the last 2 years

•Any lifetime history of suicide attempt

•History of any suicidal behavior in the last month

•History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder

•Baseline PHQ-9 score ≥15 or any suicidal ideation of level 4 or level 5 on the Columbia-Suicide Severity Rating Scale

•History or current gastroparesis (from medical history)

•Patients with obesity due to other endocrinologic disorders

•eGFR ≤60 mL/min/1.73 m2, based on Cockcroft \& Gault formula OR Participant requiring renal dialysis

•Patients with clinically Recognized Eating Disorders

•Patients with clinically significant, uncontrolled hyperthyroidism or hypothyroidism, or those with newly diagnosed thyroid disease within the past 3 months.

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Other clinical outcomes

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Heart failure

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Change from baseline in appendicular and total lean body mass and fat mass at 21 weeks

Time frame:Baseline and 21 weeks

Lean mass

change from baseline, improvement

componentsLean mass, Total fat mass

Secondary/protocol endpoint

Change from baseline in body weight at 21 weeks

Time frame:Baseline and 21 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI at 21 weeks

Time frame:Baseline and 21 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference at 21 weeks

Time frame:Baseline and 21 weeks.

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in hip circumference at 21 weeks

Time frame:Baseline and 21 weeks.

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 21 weeks

Time frame:Baseline ans 21 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in glycated hemoglobin (HbA1c) at 21 weeks

Time frame:Baseline and 21 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

1 endpoint

Secondary/protocol endpoint

Change from baseline in the 6-minute walking distance test (6MWD) at 21 weeks

Time frame:Baseline and 21 weeks

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change from baseline in low-density lipoprotein (LDL) cholesterol at 21 weeks

Time frame:Baseline and 21 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change from baseline in High-Dentsity Lipoprotein (HDL) cholesterol at 21 weeks

Time frame:Baseline and 21 weeks.

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from baseline in triglycerides at 21 weeks

Time frame:Baseline and 21 weeks.

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from baseline in systolic and diastolic pressure (SBP and DBP) at 21 weeks

Time frame:Baseline and 21 weeks.

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from baseline in SF-36 questionnaire at 21 weeks

Time frame:Baseline and 21 weeks

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in WQOL-Lite-CT physical function score

Time frame:Baseline and 21 weeks

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Other/protocol endpoint

Maximum Plasma concentration (Cmax) of 20-hydroxyecdysone (20E) and main metabolites when given concomitantly to GLP-1 receptor agonist

Time frame:Baseline, day 3 and 21 weeks

Cmax

concentration, descriptive

componentsCmax

Other/protocol endpoint

Time to reach maximum plasma concentration (Tmax) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist

Time frame:Baseline, day 3 and 21 weeks

Tmax

descriptive

Other/protocol endpoint

Area under the plasma concentration-time curve from Time zero to last quantifiable concentration (AUC0-t) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist

Time frame:Baseline, day 3 and 21 weeks

AUC₀-∞

concentration, descriptive

Other/protocol endpoint

Elimination half-life (t1/2) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist

Time frame:Baseline, day 3 and 21 weeks

Half-life

descriptive

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Change from baseline in the knee extension strength at 21 weeks

Time frame:Baseline and 21 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in the knee flexion strength at 21 weeks

Time frame:Baseline and 21 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in handgrip strength at 21 weeks

Time frame:baseline and 21 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Stair Climb Power Test (SCPT) at 21 weeks

Time frame:Baseline and 21 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline of five times Sit to Stand Test (5xSST) at 21 weeks

Time frame:Baseline and 21 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.